Addressing the Conflict: FDA vs. Torts
Our legal system supports two regulators of the safety of prescription drugs ' the U.S. Food and Drug Administration and courts applying the tort liability regime. The FDA's mission, while narrowly circumscribed in its early years, grew dramatically over the last half of the twentieth century. Today, the FDA administers the most comprehensive drug regulatory system in the world.
Antitrust Goes Global
Billions of dollars in potential awards, a new map for antitrust litigation, and what many say is a likely spot on the Supreme Court docket; <i>Empagran v. F. Hoffman-LaRoche</i> has it all. What could it mean for U.S. pharmaceutical (and other) companies? "Corporations in this country and all over the world are really scared of this," says Paul Gallagher, a Washington D.C.-based Cohen, Milstein, Hausfeld & Toll partner who serves as lead plaintiffs counsel in the case.
The Off-Label Divide
Is it ever appropriate for a drug manufacturer to disseminate information about an off-label use of a drug? If so, when is it inappropriate? Is the dissemination of such information commercial speech protected by the First Amendment that cannot be proscribed by the FDA? Can manufacturers be held accountable for this speech by the FDA or in a products liability action?
Selling a Law Practice: Prospects and Pitfalls
Large firms have long had well-defined methods for transferring ownership interests in a practice via "mergers," "retirements," "breakups," etc. Attorneys in larger firms have also always had mechanisms in place that provided them and their heirs with funding for the value of their individual interests in the firm. By contrast, the outright "sale" of a law practice from one attorney to another was prohibited for decades. In 1991, however, the ABA dropped its opposition. California had already permitted such sales since 1989, and more states have now followed suit; so the mechanisms for selling a practice have been developing, albeit slowly. These changes are economically vital for small-firm and sole practitioners. Many of these attorneys tend to conclude their law practice without any transfer of ownership, by just closing their office doors one day and never returning. By doing so, an attorney forgoes "cashing in" on a valuable asset that has taken many years to build. That no longer has to happen. Like their counterparts in large firms, sole and small-firm practitioners ' and their heirs ' can now reap the rewards of years of effort. This levels the economic playing field for retirement and estate planning.
Improving Law Firm Profitability Without Working Longer Hours or Raising Rates
Last month, in Part One of this article, I discussed three major approaches to enhancing law firm profitability: expanding your client base; assertively managing billing, receivables and payables; and unbundling operating costs from bills for fees. Previously, in the August 2003 edition of this newsletter, I described a fourth major profitability approach: management of alternative billing strategies. This month's article concludes my overview of profitability improvement methods by summarizing 10 more techniques.
Product Review: ProLaw
After considerable analysis of our firm's existing software and case management practices, we went shopping. We chose tradeshows like the ABA Techshow to familiarize ourselves with software options. Anyone who's ever attended a tradeshow knows how overwhelming the vendor presentations can be, and how after a while all products appear to blend in one's mind. It's inevitable, given the amount of information every vendor attempts to convey in each short, intense demo session. We solved that by picking up demo disks wherever possible, and then looking them over in the comfort of our own offices once we'd returned. ProLaw stood out for many reasons, including its ability to integrate all firm practice management functions under one database - something nobody else at the time was doing well, if at all.
Corporate Governance Primer: Authority of the Board
As the ultimate repository of management authority, the board of directors is spared the often laborious process by which matters are presented to it for its determination. By necessity boards must, and are entitled to, rely on corporate officers and advisers to select, refine, and present crisply for resolution the issues that come before it. The cost of such efficiency is the risk that board meetings become formulaic, board action becomes automatous, and board members fail to learn the alternatives, procedural or substantive, that might be available. This article is intended as a corporate governance primer, identifying the toggles, levers, and switches the board can set, pull, push, in the cab of the corporate crane.
Structuring a Refranchising Program
There are several things that a franchisor can do in structuring its refranchising program to reduce the likelihood of disputes and litigation. This article discusses the presale market identification and internal due diligence and initial marketing process that culminates in the execution of a letter of intent ("LOI").
Lender Liability and Its Application to Franchising
Lender liability law states that lenders must treat their borrowers fairly and, when they don't, they can be subject to borrower litigation under a variety of legal actions. Franchise relationships have seen their own share of lender liability claims. Franchisees must borrow to acquire assets, franchise agreements, and leasehold interests relating to franchise operations. Thus, franchisees, like all business borrowers, must be aware of their legal rights and legal issues that may arise during the lending relationship.
